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Trial record 62 of 641 for:    oximeter

Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03128853
Recruitment Status : Completed
First Posted : April 25, 2017
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Masimo Corporation

Tracking Information
First Submitted Date  ICMJE April 14, 2017
First Posted Date  ICMJE April 25, 2017
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE October 31, 2016
Actual Primary Completion Date November 15, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
Repeatability and reproducibility of CO-oximeter and sensor [ Time Frame: 120 minutes ]
The Repeatability and Reproducibility of the sensor will be assessed by varying the testing conditions (operator/device, finger, subject, and repetition) to determine the device and sensor's precision in SpHb measurements.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03128853 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility
Official Title  ICMJE Spot-Check Noninvasive Hemoglobin (SpHb) Repeatability and Reproducibility
Brief Summary Single-arm study to investigate the repeatability and reproducibility of SpHb measurements from the Rad-67 and DCI Mini sensor.
Detailed Description This study aims to evaluate the repeatability and reproducibility of Masimo's pulse CO-Oximeter and sensor to determine the device and sensor's precision in SpHb measurements.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Anemia
  • Healthy
Intervention  ICMJE Device: Pulse CO-Oximeter and sensor
Noninvasive Pulse CO-Oximeter device and sensor are used to evaluate SpHb.
Study Arms  ICMJE Experimental: Test subjects
Each subject receives a Pulse CO-Oximeter and sensor that will measure hemoglobin repeatedly in order to compare those measurements against a blood sample reference.
Intervention: Device: Pulse CO-Oximeter and sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2019)
57
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 15, 2016
Actual Primary Completion Date November 15, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age one month and older
  • Weight greater than or equal to 3 kg
  • The subject or the subject's legally authorized representative has given written informed consent/assent to participate in the study

Exclusion Criteria:

  • Decision-impaired adult and pediatric patients who are unable to give informed consent/assent
  • Decision-impaired adult on behalf of a pediatric patient who is unable to assent
  • Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
  • Subjects deemed not suitable for the study at the discretion of the investigator
  • Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03128853
Other Study ID Numbers  ICMJE TP-18216
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Masimo Corporation
Study Sponsor  ICMJE Masimo Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Masimo Corporation
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP